Relative Bioavailability Study With BMS-955176
- Registration Number
- NCT02095886
- Lead Sponsor
- ViiV Healthcare
- Brief Summary
The purpose of this study is to select the best dose level (amount of drug given) and best formulation of the study drug (BMS-955176) to develop further.
- Detailed Description
Primary Purpose: Other: This study will assess the bioavailability of BMS-955176 from a micronized crystalline (MC) tablet relative to a spray-dried dispersion (SDD) suspension. Assessment of additional experimental formulations relative to the micronized crystalline tablet will also be performed
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examinations, vital sign measurements, 12-lead electrocardiogram (ECG) measurements and clinical laboratory test results
- Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive. BMI = Weight (kg) / [height (m)]2
- Men and women, ages 18 to 50 years, inclusive
- Women must not be of childbearing potential, must not be breastfeeding
Exclusion Criteria
- Any significant acute or chronic medical illness
- History of cardiac disease or clinically significant cardiac arrhythmias
- Current or recent (within 3 months of study drug administration) gastrointestinal disease
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery (including cholecystectomy) that could impact upon the absorption of study drug
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1 Arm ABDC: BMS-955176 (Treatment A, B, D and C) BMS-955176 BMS-955176 single dose by mouth as specified Cohort 1 Arm BCDA: BMS-955176 (Treatment B, C, D and A) BMS-955176 BMS-955176 single dose by mouth as specified Cohort 1 Arm DABC: BMS-955176 (Treatment D, A, B and C) BMS-955176 BMS-955176 single dose by mouth as specified Cohort 1 Arm CDAB: BMS-955176 (Treatment C, D, A and B) BMS-955176 BMS-955176 single dose by mouth as specified Cohort 2 Arm EFGH: BMS-955176 (Treatment E, F, G and H) BMS-955176 BMS-955176 single dose by mouth as specified Cohort 2 Arm FGHE: BMS-955176 (Treatment F, G, H and E) BMS-955176 BMS-955176 single dose by mouth as specified Cohort 2 Arm HEFG: BMS-955176 (Treatment H, E, F and G) BMS-955176 BMS-955176 single dose by mouth as specified Cohort 2 Arm GHEF: BMS-955176 (Treatment G, H, E and F) BMS-955176 BMS-955176 single dose by mouth as specified
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) of BMS-955176 Days 1-4 of Periods 1, 2, 3 and 4 Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-955176 Days 1-4 of Periods 1, 2, 3 and 4 Area under the plasma concentration-time curve from time zero to 72 hours post-dose [AUC(0-72)] of BMS-955176 Days 1-4 of Periods 1, 2, 3 and 4
- Secondary Outcome Measures
Name Time Method Time of maximum observed plasma concentration (Tmax) of BMS-955176 Days 1-4 of Periods 1, 2, 3 and 4 Terminal plasma half-life (T-HALF) of BMS-955176 Days 1-4 of Periods 1, 2, 3 and 4 Safety and tolerability based on incidence of adverse events (AEs), serious AEs, AEs leading to discontinuation and deaths, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs and physical examinations Up to Period 4/Day 4 (discharge) Apparent total body clearance (CLT/F) of BMS-955176 Days 1-4 of Periods 1, 2, 3 and 4
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Nottingham, United Kingdom